IOM: Food, Drug Claims Need Same Evaluation

The Institute of Medicine (IOM) has released a report recommending that the Food and Drug Administration apply the same health-claims evaluation methods for foods and nutritional supplements, drugs and devices. 

Implementation of the IOM's recommended evaluation framework would represent a much higher bar for health claims made for foods and supplements.

The report concludes that there are "no rational or scientific grounds" for using different standards or methods to evaluate health claims for food and drugs, as is currently the case.

In fact, the committee of medical experts who wrote the report stressed that foods potentially present a greater risk than drugs, because larger numbers of people are exposed to food products.

The report stresses that foods should be evaluated not just on the basis of one ingredient, as they are now, but on the safety and efficacy of the entire product, as is the case with drugs.



Currently, "food manufacturers may place claims relating to the health of a food product based on the qualities of a single ingredient," the report states. "For example, a claim made about a food's ability to lower cholesterol can be made based on just a single component of that food, such as the presence of the fiber found in oats. Furthermore, some claims, such as dietary guidance statements (for example, 'dairy products may reduce the risk of osteoporosis'), can be made without any review by the FDA."

The report points out that food/supplement manufacturers frequently use changes in "biomarkers" or measures of biological processes (such as a reduction in harmful cholesterol levels) as substitutes or surrogates for actual clinical outcomes, such as heart disease or death.

The validity of using a biomarker as the basis of evaluating the safety and effectiveness of any food or drug should be assessed on a case-by-case basis, using the same, rigorous, three-part evaluation process, the committee concluded.

The report also recommends that Congress strengthen the FDA's authority so that the agency can mandate post-market monitoring of foods and drugs that have been approved based on biomarker surrogate data, and can require studies of consumers' understanding of food and supplement claims.

Bruce Silverglade, legal affairs director for the Center for Science in the Public Interest, issued a statement supporting the report's conclusions and value as a basis for the FDA to establish a comprehensive regulatory framework for health-related claims on foods and supplements.

"Misleading health-related claims on food labels are an industry-wide problem, and need an industry-wide solution," Silverglade said. "Right now, the supermarket is a jungle of unsupported health-related claims."


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